Relevant Policy

Final Two FSMA Rules (Transport and Intentional Adulteration) Finalized

The U.S. Food and Drug Administration (FDA) has recently finalized two of the remaining major rules required by the Food Safety Modernization Act (FSMA): one governing shippers, carriers, and any other entity involved in transporting food (the “Transport Rule”), and another overseeing intentional acts of adulteration in the food supply (the “Intentional Adulteration Rule”). These rules establish new, prevention-oriented requirements for points across the entire supply chain and are the last of seven major rules the FDA is expected to finalize under FSMA.

Sanitary Transport of Human and Animal Food Rule

The Transport Rule governs shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food. The rule requires said entities to use sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated (i.e., contaminated or unfit for human consumption).

The Intentional Adulteration Rule seeks to protect against intentional acts to harm the public through the food supply, including acts of terrorism. Covered facilities are required to include (and implement) a food defense plan as part of their overall food safety plan, which includes a vulnerability assessment and mitigation strategies.

This rule only applies to certain food facilities registered with the FDA. Given its scope, it is targeted toward the largest companies with the greatest distribution, and there are many exemptions. “Very small businesses,” defined under this rule as those with less than $10 million in human food sales per year (averaged over three years and adjusted for inflation), are exempt. The rule also does not apply to farms, or to “farm mixed-type facilities” doing low-risk processing.

Now that the FDA has finalized the major FSMA rules, the work turns in earnest toward implementation. Nonetheless, there are still a few remaining (but no less important) rules waiting to be issued. One of these is the clarified definition of “retail food establishment.” This final rule has been long anticipated by the local food community, as it provides critical clarity for direct marketing farms and food enterprises that could otherwise be inappropriately regulated under the facilities rule – the definition of this rule is key in determining whether or not farmers and small food enterprises are considered food facilities subject to the Preventive Controls Rule. If you have questions about whether or how the FSMA rules apply to your farm or food business, start by taking a look at NSAC’s Am I Affected flowchart.